A Trial of Tegileridine Fumarate Lnjection for Prolonged Mechanical Ventilation Abirritation in the Intensive Care Unit (ICU)
Recruiting now · Phase 2
Conditions studied: Abirritation in the ICU
In brief
The purpose of this study is to evaluate the efficacy and safety of Tegileridine Fumarate lnjection for prolonged abirritation(48h to 72h) during mechanical ventilation in the ICU.
Key facts
- Study ID
- NCT07372924
- Run by
- Jiangsu HengRui Medicine Co., Ltd.
- People needed
- 120
- Starts
- 2026-02-24
- Expected to finish
- 2026-07-01
- Last updated by the study team
- 2026-03-13
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients or their guardians are able to provide a written informed consent
- Subjects have been treated with endotracheal intubation and mechanical ventilation ≤24h, and then prolonged mechanical ventilation ≥48h in the next
- Age ≥ 18 and ≤ 85 years, Male or female
- Body mass index (BMI) > 18 and < 30 kg/m2
- Use of highly effective contraception for a specified period if applicable
You may not qualify if…
- Those who are known or suspected to be allergic or contraindicated to various components of the experimental drugs involved in the research institute
- With an expected survival time of less than 48 hours
- unable to undergo CPOT and RASS assessments due to various reasons, such as a history of psychiatric disorders, neurological disorders, neurological dysfunction, and consciousness disorders, as well as blindness, deafness, or aphasia
- Myasthenia gravis, bronchial asthma attack, acute intestinal obstruction, abdominal compartment syndrome
- Multiple organ failure
- Malignant tumor Subjects who received radiotherapy, chemotherapy, targeted therapy, and immunotherapy within the first month of randomization
- Chronic pain requires long-term use of analgesics
- Severe liver dysfunction
- Severe renal dysfunction
- Severe renal dysfunction
- Need to receive deep sedation or use neuromuscular blocking drugs
- Surgery or tracheotomy may be required during the study administration period
- Used monoamine oxidase inhibitors within the two weeks randomization
- History of drug abuse, drug use, alcohol abuse, and long-term use of psychotropic drugs within 2 years prior to the start of the screening period
- QTc abnormality during screening period
- Positive result for infectious disease
- Positive screening for drug abuse
- Pregnant or nursing women;
- Subjects who has Participated in any other clinical trials within the first 3 months of randomization
- Other conditions deemed unsuitable to be included.
Where it is running
- Zhongshan Hospital — Shanghai, Shanghai Municipality, China (enrolling)
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Hubei, Wuhan, China (enrolling)
Full record on ClinicalTrials.gov
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